Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

Medication Adherence Clinical Trial

— BP  

Official title:

Blister Packaging Medication to Increase Treatment Adherence and Clinical Response: Impact on Suicide-Related Morbidity and Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118208
• Other study ID #: W81XWH-09-1-0723
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: October 18, 2017
• Start date: September 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2017
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This quantitative, interview-based study will determine if increased prescription medication adherence via blister pack administration will reduce suicide related behavior among the high risk population of patients discharged from a psychiatric inpatient unit. The aims of the project are to determine whether blister packaging medication significantly increases treatment adherence and if blister packaging significantly decreases intentional self-poisoning behavior (i.e., suicide attempts and completions). By tracking former psychiatric inpatients for 12 months post-discharge and obtaining monthly medication adherence ratings, we will determine if blister packaging (BP) medications leads to better adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report and medical record review) of suicide-related behaviors, we will determine if patients in the BP condition have less intentional self-poisoning behavior than those in the DAU condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 or older

• diagnosed with major affective disorder,

• bipolar affective disorder,

• post-traumatic stress disorder, or

• schizophrenia (or any combination of these diagnoses)

• under voluntary status at some point during admission

• currently prescribed medications

• deemed capable of managing their own medications after discharge

• not currently active duty in any branch of the military

• able to correctly answer questions verifying they understand the consent form

• English-Speaking

Exclusion Criteria:

• Under the age of 18

• Not under voluntary status at some point during admission

• Not currently prescribed medications

• Not able to manage their own medications after discharge

• Non-English-speaking

• Currently active duty in any branch of the military

• Inability to correctly answer questions indicating comprehension of information on the consent form

Related Conditions & MeSH terms

• Accidental Overdose
• Blister
• Deliberate Overdose
• Drug Overdose
• Medication Adherence
• Suicide
• Suicide, Attempted

Intervention

Other:
• Blister packaging medications
Dispensing prescription medications on pre-filled blister package cards.
• Dispense as usual
Dispensing prescription medications in standard pill bottles.

Locations

Country	Name	City	State
United States	Denver VA Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gutierrez PM, Wortzel HS, Forster JE, Leitner RA, Hostetter TA, Brenner LA. Blister Packaging Medication Increases Treatment Adherence in Psychiatric Patients. J Psychiatr Pract. 2017 Sep;23(5):320-327. doi: 10.1097/PRA.0000000000000252. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence as assessed with the Brief Adherence Rating Scale (BARS)		monthly for 12 months
Secondary	Medication overdoses as measured by the Self-Harm Behavior Questionnaire (SHBQ)	Both accidental and intentional overdoses will be assessed.	monthly for 12 months